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Efficacy of Yangyin Yiqi Huoxue Granule (养阴益气活血颗粒) in Treatment of Ischemic Stroke Patients with Qi-Yin Deficiency and Blood Stasis Syndrome: A Randomized, Double-Blind, Multicenter, Phase-2 Clinical Trial

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Chinese Journal of Integrative Medicine Aims and scope Submit manuscript

Abstract

Objective

To evaluate the efficacy and safety of Yangyin Yiqi Huoxue Granule (养阴益气活血颗粒, YYHG) in the treatment of ischemic stroke (IS) patients with qi-yin deficiency and blood stasis syndrome (QYDBSS), and to explore its effective dosage.

Methods

The total of 288 patients were randomly assigned to the YYHG high-dose, YYHG low-dose, positive control (administered Xiaoshuantong Granule, XSTG, 消栓通颗粒), or placebo control (administered inert granule) groups (72 cases per group) by software-drived competitive block randomization. The trial was conducted for a 28-day period, with a 180-day follow-up period. The primary outcome was the comprehensive curative evaluation, and secondary outcomes were the National Institute of Health Stroke Scale (NIHSS) score, Barthel activities of daily living (ADL) index score, the quality of life index (QLI) score, and the Chinese medicine syndrome (CMS) score. All analyses were done on an intention-to-treat basis. The clinical safety was also assessed.

Results

The total of 288 participants were recruited between June 1, 2008 and September 30, 2009, and 287 patients received intervention; the treatment groups were well balanced at baseline. The comprehensive cure rates of YYHG high-dose, low-dose, positive and placebo control groups were 63.38%, 31.94%, 36.11% and 6.14%, respectively; there was a statistical difference between the two groups (P<0.01), while the high-dose YYHG treatment group was significantly higher than the other 3 groups (P<0.01). The improvement of NIHSS, ADL, QLI and CMS scores of the YYHG high-dose and low-dose groups was significantly better than that of the positive control group and the placebo control group (P<0.05). In terms of improving the classification of the NIHSS scale and the assessment of the ADL scale, the YYHG high-dose group was significantly better than the other three groups (P<0.05), and the YYHG low-dose group was better than the placebo control group (P<0.01). At the same time, except for the QLI score, the high-dose group was better than the low-dose group (P<0.05). In terms of safety, adverse reactions after YYHG treatment were generally mild (3.78%), and no serious adverse reactions have been reported.

Conclusion

YYHG is safe and effective in the treatment of IS patients with QYDBSS.

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Acknowledgments

We thank the physicians of the eight hospitals for their contribution to this study and the patients for their participation in our study.

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Authors and Affiliations

  1. Institute of Cardio-Cerebrovascular Disease, Zhejiang Chinese Medical University, Hangzhou, 310053, China

    Yu Wang, Jie-hong Yang, Hai-tong Wan, Yu He, Hui-fen Zhou, Li Yu & Hao-fang Wan

  2. Neurology Department, Xinhua Hospital of Zhejiang Province, Hangzhou, 310005, China

    Bin Xu

  3. Neurology Department, Integrated Medicine Hospital of Jilin Province, Yanbian, Jilin Province, 133001, China

    Chang-shan Ai

  4. Chinese Medicine Department, the Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, 310000, China

    Xiao-dong Bie

Authors
  1. Yu Wang
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  2. Jie-hong Yang
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  3. Hai-tong Wan
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  4. Yu He
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  5. Bin Xu
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  6. Chang-shan Ai
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  7. Hui-fen Zhou
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  8. Li Yu
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  9. Hao-fang Wan
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  10. Xiao-dong Bie
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Contributions

Wan HT, Yang JH, and He Y contributed to the conception and design of the study. Xu B and Ai CS were the principal investigator who conducted the pilot study. Wan HF and Bie XD collected data, Zhou HF and Yu L performed data analysis, Wang Y drafted the manuscript. All authors contributed to further writing of the manuscript, and read and approved the final version.

Corresponding author

Correspondence to Hai-tong Wan.

Ethics declarations

The authors declare that they have no competing interests.

Additional information

Supported by the National Natural Science Foundation of China (No. 81630105, No. 81374053, No. 81173647), Zhejiang Provincial Natural Science Foundation of China (No. LZ17H270001) and Zhejiang Provincial Program for the Cultivation of High-Level Innovative Health Talents (No. 2018R1002)

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Wang, Y., Yang, Jh., Wan, Ht. et al. Efficacy of Yangyin Yiqi Huoxue Granule (养阴益气活血颗粒) in Treatment of Ischemic Stroke Patients with Qi-Yin Deficiency and Blood Stasis Syndrome: A Randomized, Double-Blind, Multicenter, Phase-2 Clinical Trial. Chin. J. Integr. Med. 27, 811–818 (2021). https://doi.org/10.1007/s11655-021-2857-0

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  • DOI: https://doi.org/10.1007/s11655-021-2857-0

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